MR Patient Care Infant SpO2 Grips (20) 989803166571

GUDID 00884838117907

Box of 20 Disposable SpO2 finger grips designed for use with the Quick Connect SPO2 Sensor (989803161991) - Sized for Infant patients

Philips Medizin Systeme Böblingen GmbH

Pulse oximeter probe, single-use
Primary Device ID00884838117907
NIH Device Record Key61aa470a-7695-46e7-bca9-30c45863ab51
Commercial Distribution StatusIn Commercial Distribution
Brand NameMR Patient Care Infant SpO2 Grips (20)
Version Model NumberInfant SpO2 Grips (20)
Catalog Number989803166571
Company DUNS314101143
Company NamePhilips Medizin Systeme Böblingen GmbH
Device Count20
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838117907 [Unit of Use]
GS110884838117904 [Primary]

FDA Product Code

MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-28
Device Publish Date2025-05-20

Devices Manufactured by Philips Medizin Systeme Böblingen GmbH

00884838117198 - patient lead wire2026-01-26 Complete Lead Set for PageWriter TC Series Cardiographs, AAMI Color Coded. Consisting of 2 arm leads (39"(1m)), 2 leg leads (41"
00884838117204 - patient lead wire2026-01-26 Complete Lead Set for PageWriter TC Series Cardiographs, IEC Color Coded. Consisting of 2 arm leads (39"(1m)), 2 leg leads (41"
00884838117211 - patient lead wire2026-01-26 Long complete lead set for PageWriter TC Series Cardiographs, AAMI color coded. Consisting of 2 long arm leads (54" (1,37m)), 2
00884838117228 - patient lead wire2026-01-26 Long complete lead set for PageWriter TC Series Cardiographs, IEC color coded. Consisting of 2 long arm leads (54" (1,37m)), 2 l
00884838086678 - Masimo Sedline Module2026-01-23 Masimo SedLine Plug-in Module for IntelliVue Patient Monitors to connect the Masimo SedLine Measurement Device (989803203051)
00884838117259 - patient lead wire2026-01-23 Limb lead set for PageWriter TC Series Cardiographs, AAMI and IEC color coded. Consisting of 2 arm leads (39",99cm), 2 leg leads
00884838117266 - patient lead wire2026-01-23 Long Limb lead set for PageWriter TC Series Cardiographs, AAMI and IEC color coded. Consisting of 2 long arm leads (54",1,37m),
00884838117235 - patient lead wire2025-12-23 Chest lead Set for PageWriter TC Series Cardiographs AAMI and IEC color coded, consisting of one 1 in 3 (Trident) Lead ( 28" (70

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.